BARDA’s Division of Research Innovation and Ventures (DRIVe) announced Thursday that it will partner with US Biologic Inc. to develop an oral vaccine for two strains of the influenza virus.
Part of BARDA DRIVe’s Beyond the Needle program, the partnership’s goal is to make vaccines and therapeutics more widely available, as well as easier to administer, without the need for needles, syringes, vials, and cold-chain distribution burdens.
While an essential and lifesaving tool to prevent influenza, most vaccines are administered as intramuscular shots. Additionally, current influenza vaccines require complex manufacturing processes and cold chain storage that, in a pandemic, may create delays for vaccinations.
“US Biologic currently has an oral delivery platform for animal vaccines that has been demonstrated to be safe, efficacious, and cost-effective for other infectious diseases with pandemic potential,” the companies said. “This contract will allow US Biologic to collect sufficient data to submit an IND application to the U.S. Food and Drug Administration with the goal of entry into Phase I clinical trials for an oral influenza vaccine using this platform technology for humans.”
According to US Biologic, its OrisBio platform would utilize a series of tools that protect antigens from the harsh environment of the stomach while allowing for target gut delivery of vaccine proteins to protect against disease. The specific formulation of the gut-stabilized antigen provides for release in the duodenum and induces immune stimulation and protection.
The company said the platform supports recombinant antigens and avoids the use of inactivated or live attenuated pathogens in the vaccines, a design that allows for high throughput, low cost, and thermostability, all factors that are favorable to vaccine development in the midst of a pandemic.